Merck wins FDA approval for first oral PCSK9 cholesterol pill

Jul 16, 2026

The U.S. FDA has approved Merck's Lipfendra, the first oral PCSK9 inhibitor pill for high cholesterol. Priced at $10.50 per day, the once-daily drug reduced "bad" LDL cholesterol by up to 60% in trials. The approval provides a new treatment alternative to injectables and helps Merck diversify its portfolio as its blockbuster cancer drug, Keytruda, faces patent expiration in 2028.

FDA approval for Lipfendra

▪Lipfendra is a once-daily pill intended to treat hypercholesterolemia, which is identified by elevated levels of LDL or "bad" cholesterol.
▪The FDA's approval was based on two late-stage trials that showed the pill significantly lowered LDL cholesterol in patients, including those already taking statins.
▪The U.S. Food and Drug Administration (FDA) approved Merck's cholesterol pill, Lipfendra, on July 16, 2026.
▪In clinical studies, Lipfendra reduced bad LDL cholesterol levels by up to 60% over six months in adults with or at risk for atherosclerotic cardiovascular disease.

PCSK9 inhibitor mechanism

▪According to the American Heart Association, about one in four adults in the U.S. have high LDL cholesterol.
▪Lipfendra is the first oral PCSK9 inhibitor to be approved and enter the market.
▪The drug works by blocking the PCSK9 protein, which plays a vital role in regulating cholesterol levels.
▪This mechanism differs from oral statins, which block an enzyme the liver uses to make cholesterol.

Merck portfolio diversification

▪Keytruda is set to lose key patent protections starting in 2028, exposing Merck to competition from less expensive biosimilar versions.
▪The approval of Lipfendra helps Merck diversify its portfolio beyond its blockbuster cancer drug, Keytruda.

Daily list price

▪The list price for Lipfendra will be $10.50 per day, based on a 30-day supply.
▪Merck will sell Lipfendra for about $3,800 a year.

Peak sales potential

▪Following the approval announcement, Merck's shares rose 1.1% in premarket trading.
▪A Scotiabank analyst projected Lipfendra could have "peak sales potential of tens of billions of dollars."

Competitive injectable alternatives

▪Lipfendra provides an oral alternative to a class of cholesterol-lowering drugs long dominated by injectables.
▪The market for PCSK9-inhibitor drugs is currently dominated by injectables like Amgen's Repatha and Regeneron and Sanofi's Praluent.